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Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02183142
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany

Condition or disease Intervention/treatment Phase
Healthy Drug: Mobic, China, 7.5 mg Drug: Mobic, Germany, 7.5 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of 7.5 mg Mobic Tablet Manufactured in China in Comparison With 7.5 mg Tablets Manufactured in Germany After a Single Oral Dose in Chinese Healthy Volunteers, Open, Randomized, Two Way Crossover Trial
Study Start Date : March 2001
Actual Primary Completion Date : April 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arm Intervention/treatment
Active Comparator: Mobic Germany Drug: Mobic, China, 7.5 mg
Drug: Mobic, Germany, 7.5 mg
Experimental: Mobic China Drug: Mobic, China, 7.5 mg
Drug: Mobic, Germany, 7.5 mg



Primary Outcome Measures :
  1. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: Up to 96 hours after drug administration ]
  2. Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity) [ Time Frame: Up to 96 hours after drug administration ]

Secondary Outcome Measures :
  1. Time to achieve Cmax (tmax) [ Time Frame: Up to 96 hours after drug administration ]
  2. Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t) [ Time Frame: Up to 96 hours after drug administration ]
  3. Terminal rate constant in plasma (λ) [ Time Frame: Up to 96 hours after drug administration ]
  4. Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: Up to 96 hours after drug administration ]
  5. Mean residence time of the analyte (MRT) [ Time Frame: Up to 96 hours after drug administration ]
  6. Apparent clearance of the analyte in plasma following extravascular administration (CL/F) [ Time Frame: Up to 96 hours after drug administration ]
  7. Apparent volume of distribution following extravascular administration (Vd/F) [ Time Frame: Up to 96 hours after drug administration ]
  8. Number of patients with clinically relevant changes from baseline in laboratory values [ Time Frame: Baseline, up to day 5 after last drug administration ]
  9. Number of Participants with Adverse Events [ Time Frame: Up to day 5 after last drug administration ]
  10. Number of patients with clinically relevant changes from baseline in physical examination (pulse rate, systolic and diastolic blood pressure) [ Time Frame: Baseline, up to day 5 after last drug administration ]
  11. Global assessment of tolerability by investigator on a 4-point scale [ Time Frame: Day 5 after last drug administration ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chinese healthy male volunteers as determined by result of screening
  • Written informed consent in accordance with Good Clinical Practice (GCP)
  • Age >= 18 and <= 40 years
  • Broca > - 20% and < + 20%

Exclusion Criteria:

  • Any finding of the medical examination (blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
  • Surgery of the gastro-intestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Chronic or relevant acute infections
  • Hypersensitivity to Mobic and/or non-steroidal anti-inflammatory drugs
  • Intake any drugs within 1 month before randomization
  • Participation in another trial with an investigational drug within the last 2 month or during the trial
  • Smokers ( >= 10 cigarettes or >= 3 cigars or >= 3 pipes/day) or inability to refrain from smoking on study days
  • Alcohol or drug abuse
  • Blood donation within the last 1 month
  • Excessive physical activities within the last 5 days
  • History of hemorrhagic diatheses
  • History of gastro-intestinal ulcer, perforation or bleeding
  • History of bronchial asthma

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183142     History of Changes
Other Study ID Numbers: 107.234
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action